Respectful Insolence

Finally, the FDA acts on TheDCASite.com

It sure took the FDA long enough, nearly five months, but it finally acted. It finally shut Jim Tassano down, as this notice on TheDCASite.com states:

Two agents from the FDA visited us on Tuesday,July 17, 2007 and ordered that we stop making and selling DCA. Unfortunately, the site www.buydca.com will be shut down immediately.

It is against US government law to sell substances with the suggestion that they are cancer treatments unless they are approved by the FDA.

DCA can still be obtained from pharmacies with a prescription and from chemical companies.

To keep you informed and abreast of new developments and potential cancer treatments, www.thedcasite.com will continue.

Thank you for all your support.

Jim Tassano & the DCA Team

And, on the discussion boards:

Two agents (Chris and Steve) from the U.S. Food and Drug Administration’s Office of Criminal Investigations, San Francisco, arrived unannounced at about 11:30 am, on July 17, 2007 at our pest control office in Sonora California. They walked in, like men on a mission, I am told, and said “I need to speak to James Tassano”.

I wasn’t at that office. Our manager Eric called and informed me that 2 men from the FDA had come to see me. I was with Ilene, getting ready for a noon appointment. I spoke to Chris and told him I could meet him afterwards. We arranged to meet at 1:30.

Ilene and I drove down to that office, arriving 10 to 15 minutes early. The agents were standing next to their car, waiting. They were dressed in polo shirts and slacks. The four of us went into a conference room.

Chris said “this won’t take long.” He got to the point and said that we were manufacturing DCA as a cancer cure. He said something about the FDA orange book having some regulations that we had violated. 21 CFR 312, and 21 USC 321 and 352. He read a few others that went by faster than I could write.

I explained that we made no claims on the www.buydca.com site, no advertising, made no mention that we were offering DCA to treat cancer. Our site does state that it was the same material used in the University Of Alberta studies, but that was all.

However, they stated what counted was our “intent”. Since DCA is not an FDA-approved cancer drug, if our intent was to sell it as such, despite the lack of claims or statements we were in violation.

Our case had been run by the US Attorney General’s Office which recommended that we be told to not make and sell DCA. We had committed a misdemeanor, but now that we were warned, we could be cited with a felony.

We were told to stop making and selling DCA. No paperwork passed hands, either way.

The meeting was relatively brief. The agents were polite but firm. They had no interest in hearing much of anything, and did not care if it worked. They said we needed to contact the regulatory side of the FDA if we wanted to pursue anything. And that it was very costly to develop a drug. They were good ‘company men’ for the FDA.

All I can say is: What took the FDA so long?

Naturally, it didn’t take long for the conspiracy-mongering to start, particularly the comparisons of the FDA to Nazis, something so predictable and a comparison so mundane that it really wasn’t worth dragging the poor old undead Führer out of his crypt to mock. For example:

They’re full of it.
The gestapo tactics used by these “officials” are a crime.

Matter of fact, I suggest a class action lawsuit under conspiracy.

Not only are they disallowing a substance that is not illegal or harmful to have without a prescription, but they themselves have no substantiated claims that it DOES NOT act as a deterrent or aide in the positive progress against carcinomas.

[…]

You want to know the real Felon? Try the FDA and the large Medical firms around the globe… The ones that put fear into those of us who can only afford less-than-average ways to try and help ourselves.

It’s a money game. If it works, and they see it as a possible profit loss, its pretty much game over for the little guys. Maybe even population control…

3 years from now, you’ll see DCA being mass-marketed by someone like pfizer or some big-wig company making a mint off of it, while you, good sir, wont get a single red cent.

And, of course, the conspiracy-mongering started, particularly the “FDA is a tool of big pharma” sort. For example:

Of course the FDA shut down buyDCA.com – it’s because we’ve been proving that DCA is an effective cancer treatment, and they wouldn’t want Big Pharma to have AAAAANNNNYY competition now would they!!

What an infringement on the rights of the individual!! DCA is not a drug, it is a chemical. How dare they shut down cancer patients’ access to a life saving treatment!!

Talk about stupid. All drugs are chemicals. Anything chemical or mixture of chemicals that has a physiological effect on the human body (or in animals) is a drug, particularly if that effect can be used for therapeutic effect. There was plenty of paranoid conspiracy-mongering elsewhere, too:

DCA must be a hot item (it most work real good on cancer) for the FDA to restrict DCA sales. That is my guess.

No, it didn’t. At least it was not a miracle cure, and there were not even any testimonials that, when critically examined, supported its being a “hot item.” There was plenty more where that came from:

In my opinion, this is a classic example of the FDA overstepping its boundaries of “protecting” people from their own preferred medical treatments, while forcing them to return to “medically accepted,” but in my humble opinion, rather medieval methods of treatments (pick between getting poisoned, burned, or cut…. or combine a mix of each…?)…. And in so doing, the FDA protects the monopoly status of very expensive drugs that offer results that are not better, and sometimes are worse. (Note that a single infusion of Rituxan , for example, a monoclonal antibody made by Genentech, and commonly used against blood-based cancers, costs some US$10,000 each, and patients usually need at least four courses of treatment before getting some relief…. other branded chemotherapy agents are as least as expensive if not more so… and they are rarely curative…..)

No, it’s a case of the FDA finally getting off of its duff and enforcing the law.

All of this lead Heather Nordstrom (whom we’ve also met before) to make the most hilariously disingenuous statement I’ve heard in a very long time:

They came to their conclusion somehow by reading the sites and thinking that our intent was to sell for the treatment of cancer. Tha was enough “evidence” for them. Apparently we cannot sell it for the treatment of animal’s cancer either.

Of course, months ago, I provided copious evidence from the DCA Site itself that the whole “Pet-DCA” thing was nothing more than a ruse to try to provide plausible deniability in case the FDA came calling and lots of quotes from the DCA Site itself that showed that the intent was clearly to sell DCA to treat humans. Then there was all the discussion about the use of DCA on the DCA Site forums, facilitated by Jim Tassano and Heather Nordstrom. Come on, Heather, just how stupid do you think people are? Even if the FDA were as clueless as you think it is, you and Jim made it exceedingly obvious that you intended to sell this stuff to humans to treat human cancer. Jim even said so himself in at least one interview, oh-so-piously assuring the interviewer that it would be wrong not to be upfront about what he is doing. Now that you’re busted, you’re not only whining, but you’re lying about your original intent. Clearly Heather has nothing but contempt for anyone who supports evidence-based medicine and might read this.

Most frighteningly, one commenter suggested buying DCA from Sigma Chemical Company. This is not a good idea at all, given that this is not pharmaceutical grade DCA. Very likely, it won’t be completely neutralized to pH 7.0 in solution, and you don’t know what other impurities it might have in it.

I certainly hope that DCA turns out to be a highly effective cancer treatment. Unfortunately, most of the testimonials on the DCA Site were, when critically examined, negative, nothing more than wishful thinking, while the ones that seem as though DCA was effective were probably a classic case of attributing the “cure” to DCA when taking all sorts of other conventional anticancer therapy and alternative supplements, although it’s certainly possible that DCA was synergistic with conventional therapy in this case.

I also hope that you and I played some small role in bringing this about when I urged you all a few months ago to file complaints with the FDA about The DCA Site. The denizens of the site are correct about one thing, though. Even though Tassano’s operation has been shut down, it’s virtually certain that someone somewhere (presumably in a country with more lax drug regulations) will set up shop again and start selling the stuff. The best way to help cancer patients is not to try homebrew chemotherapy drugs on them without medical supervision. (And make no mistake, DCA is chemotherapy.) Rather, it is to make sure through well-designed randomized clinical trials that the drugs we propose to give them are actually effective against their cancer before subjecting them to their potential toxicities.

My only regret is that Jim Tassano got away with just a warning. He should have been hit with a big fine at least or even given a jail sentence. On the other hand, doing so would have created a martyr to the cause; so maybe it’s better this way.

All Orac posts on DCA:

  1. In which my words will be misinterpreted as “proof” that I am a “pharma shill”
  2. Will donations fund dichloroacetate (DCA) clinical trials?
  3. Too fast to label others as “conspiracy-mongers”?
  4. Dichloroacetate: One more time…
  5. Laying the cluestick on DaveScot over dichloroacetate (DCA) and cancer
  6. A couple of more cluesticks on dichloroacetate (DCA) and cancer
  7. Where to buy dichloroacetate (DCA)? Dichloroacetate suppliers, even?
  8. An uninformative “experiment” on dichloroacetate
  9. Slumming around The DCA Site (TheDCASite.com), appalled at what I’m finding
  10. Slumming around The DCA Site (TheDCASite.com), the finale (for now)
  11. It’s nice to be noticed
  12. The deadly deviousness of the cancer cell, or how dichloroacetate (DCA) might fail
  13. The dichloroacetate (DCA) self-medication phenomenon hits the mainstream media
  14. Dichloroacetate (DCA) and cancer: Magical thinking versus Tumor Biology 101
  15. Checking in with The DCA Site
  16. Dichloroacetate and The DCA Site: A low bar for “success”
  17. Dichloroacetate (DCA): A scientist’s worst nightmare?
  18. Dichloroacetate and The DCA Site: A low bar for “success” (part 2)
  19. “Clinical research” on dichloroacetate by TheDCASite.com: A travesty of science
  20. A family practitioner and epidemiologist are prescribing dichloracetate (DCA) in Canada
  21. An “arrogant medico” makes one last comment on dichloroacetate (DCA)

Posts by fellow ScienceBlogger Abel Pharmboy:

  1. The dichloroacetate (DCA) cancer kerfuffle
  2. Where to buy dichloroacetate…
  3. Local look at dichloroacetate (DCA) hysteria
  4. Edmonton pharmacist asked to stop selling dichloroacetate (DCA)
  5. Four days, four dichloroacetate (DCA) newspaper articles
  6. Perversion of good science
  7. CBC’s ‘The Current’ on dichloroacetate (DCA)

Comments

  1. #1 Bronze Dog
    July 20, 2007

    The heroic FDA finally gets off its duff and slays the evil, unethical, profit-by-any-means company.

    ‘BOUT TIME!

  2. #2 Matt the heathen
    July 20, 2007

    Great work on this issue…

  3. #3 sailor
    July 20, 2007

    I think they got off very lightly. If those had been psychoactive drugs it would have been jail. In some ways this is much worse.

  4. #4 wolfwalker
    July 20, 2007

    Five months, Orac? For a federal agency, that’s almost unimaginably fast action. Kudos to whomever decided to cut the red tape and get Tassano shut down.

  5. #5 vlad
    July 20, 2007

    I actually quite curious. Why now? I’m wondering if someone actually had a bad reaction to the stuff. Legally the DCA quacks have protected themselves. I’m pretty sure he had a law team ready to fight, they did nothing. Why would someone surrender to the FDA without a fight? I’m guessing that they had him dead to rights on something.

    If DCA works then as with all real drugs there is the chance of over dose.

  6. #6 Gerard Harbison
    July 20, 2007

    Most frighteningly, one commenter suggested buying DCA from Sigma Chemical Company. This is not a good idea at all, given that this is not pharmaceutical grade DCA. Very likely, it won’t be completely neutralized to pH 7.0 in solution, and you don’t know what other impurities it might have in it.

    No kidding. DCA has a pKa of 1.25. That’s a pretty strong acid. Take it neat, and you’ll burn your mouth and esophagus.

  7. #7 Orac
    July 20, 2007

    I actually quite curious. Why now? I’m wondering if someone actually had a bad reaction to the stuff.

    Interesting thought, one that perhaps I should have thought of. Now that you mention it, I do wonder if someone was taking DCA without telling their oncologist and had a bad reaction or even died. Certainly a few of the regulars did take DCA without telling their doctors. It’s less likely that someone would have died from taking DCA alone, but also possible.

  8. #8 jre
    July 20, 2007

    Excellent question regarding possible adverse reactions.
    When this topic first came up, the theory was advanced that no research was being funded into pharmacologic uses of DCA because the chemical could not be patented; thus, there was no interest from industry; thus, the government research arm would not fund studies. I looked for “dichloroacetate” in CRISP, and found that DCA was being studied as a possible drug (albeit for treatment of mitochondrial encephalomyopathies) and also for its toxicology, for example see this:

    The cardinal manifestations of chronic DCA exposure are reversible hepatotoxicity and peripheral neuropathy (PN) in humans and hepatic neoplasia and reversible neurotoxicity in rodents.

    Hmmm …
    On a distinct but related note, I wonder if anyone who advanced the “no profit potential, so no research” theory is now complaining that the FDA raid was intended to shut down Big Pharma’s competition. Not that I would ask for consistency or anything.

  9. #9 Coin
    July 20, 2007

    It is against US government law to sell substances with the suggestion that they are cancer treatments unless they are approved by the FDA.

    Who would have guessed?

  10. #10 Coin
    July 20, 2007

    So has there been, or should we expect anytime soon, any progress toward an actual clinical trial of DCA as a cancer treatment?

  11. #11 Porlock Junior
    July 21, 2007

    One DCA freak suggests buying your own from Sigma; Orac is properly upset at the idea of people messing with nonpharmaceutical-grade stuff; Gerard Harbison documents how bad it would clearly be if somebody got some and tried to drink it.

    But it’s all their fancy, that. Buy some from a chemical supplier? This reminds me of Galbraith’s chapter on the worries about inflation in the 1930s: The Threat of the Impossible. You can’t buy chemicals from a chemical company! Sheltered, privileged academics like Orac may be only vaguely aware of it; they should just try someday, but leaving their university affiliations at home.

    In the interest of science, I tried it at the Sigma site. Looked up a chemical I like to use, potentially fatal in excessive doses, secret formula: NaCl. Never fear; I can no more bankrupt the family by putting this stuff on my potatoes at $10 a pound than your DCA-site reader can poison himself with product from Sigma.

  12. #12 Orac
    July 21, 2007

    Porlock has a point here. On the other hand, how difficult would it be for people to find an academic or chemist with a university affiliation to buy some of this stuff for them? I don’t know, but I suspect there are probably some chemists and scientists out there who could be talked into it.

  13. #13 S. Rivlin
    July 21, 2007

    What, if any, were the impurities of Jim Tessano’s DCA? My guess is his preparation is less pure than Sigma’s. As to the calls to conduct clinical studies of DCA anticancerous potential, how about Jim Tessano turning his profits from selling DCA to his “patients” toward that purpose.

  14. #14 Abel Pharmboy
    July 22, 2007

    Indeed. A commenter just left this:

    I wrote to the FDA with this comment:

    “I bought DCA from buyDCA.com and had it tested by a chemist. He found that it was more impure than the industrial grade DCA I bought from a major US supplier.”

    I had also shared this information with buydca.com as well.

  15. #15 Steven
    July 22, 2007

    I don’t know what to think of it. Most people in thedcasite.com feel that the FDA is opposing them, by taking away a treatment option. I am not saying that DCA is either safe or effective, but the strange thing is that most people in the forum do not like what the FDA did, saying that they can judge for themself what is good for them.

    It’s really difficult, can we take away something people really want to have, despite all the safety and ineffectivity warnings.

  16. #16 qetzal
    July 22, 2007

    It’s really difficult, can we take away something people really want to have, despite all the safety and ineffectivity warnings.

    FDA was created and granted increasing power because ‘we’ didn’t want bogus or inadequately tested drugs being sold.

    Now ‘we’ are mad that FDA tries to tell us what we can and can’t do when it comes to inadequately tested drugs.

    Can’t have it both ways.

  17. #17 Steven
    July 23, 2007

    Now the difficult part:

    What if dichloroacetate is in fact really effective or what if apricot pits are in fact really effective. Not only effective, but also very cheap and safe. Now the FDA takes away both the dichloroacetate and the apricot pits.

    Subsequently there is no pharmaceutical company able or interested in researching the dichloroacetate or apricot pits, because they are not financially interesting.

    Then, the people realise that these two things are really good against cancer and generate alot of good testimonials. Then it’s only natural that people start selling apricot pits.

    Then… The FDA, being pressured by the pharmaceutical industry, is going to stop the selling. After all, it’s only fair that if the pharmaceutical industry has to test their drugs, other people should not be selling “drugs” that have never been tested well.

    These drugs will never be tested well, due to disinterest from pharma.

    And so there will always be people breaking the law to sell apricot pits.

    Analogy is that I have a car, but a new law states that I can never drive faster then 30 mph on the highway. But if I drive 30 mph, I have to drive 3 hours to work. What do I do now? I have a brand new car, should I break the law or drive 3 hours to work instead.

    Well, if the law states that I can never drive faster then 80 mph, it’s acceptable. If the FDA can give me a good, cheap alternative to the apricot pits, it’s acceptable.

    So if the FDA takes away “my” apricot pits they should supplement me with something that is almost just as good, effective and CHEAP, otherwise I may break the law.

  18. #18 qetzal
    July 23, 2007

    Steven,

    FDA’s actions are not a matter of being ‘fair.’ They’re a matter of law. It’s illegal in the US to sell drugs unless they’ve been approved by FDA based on adequate evidence of safety and efficacy.

    Implying that DCA and laetrile are not “drugs” doesn’t help. Legally, the term “drug” includes:

    “(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals…” (Federal Food, Drug, & Cosmetic Act, Sec. 201(g)(1)).

    If I sell sodium chloride to sprinkle on your steak, I’m not selling a drug. But if I sell sodium chloride to inject into your veins, I’m selling a drug and it has to be approved by FDA.

    FDA didn’t invent those laws. They were passed by Congress, in response to public outcries against harms caused by drugs that didn’t work or were unsafe.

    In a very real sense, we (the US public) decided that no-one should sell untested drugs. We created the FDA to ensure that. If we want that to change, we need to get Congress to change the laws. (Of course, that may be difficult, and established pharma co.s would probably try to prevent it, but those problems don’t change the underlying facts.)

    However, things aren’t as dire as you suggest. Consider your hypothetical really effective, very cheap, and safe anticancer drug. Academic and government groups are free to develop it, even if industry isn’t interested. If it’s really effective, very cheap, and safe, a research oncologist could easily do small-scale studies in cancer patients, using funding from NCI. If it’s really effective and safe, a Phase 1/2 study of 30-40 people would show compelling benefit.

    Note that there’s plenty of incentive for this to happen. Imagine the fame and reward that would come to any oncologist who demonstrated such a benefit.

    At that point, the government could take over development. They could do it directly, running larger trials through NIH and contracting out manufacture, or they could incentivize industry to do it (just like they have for things like pandemic flu vaccines).

    So, why hasn’t that happened yet for DCA? I can think of two reasons.

    A) DCA is just one of hundreds of compounds that have interesting activity in cells and animal models. It’s worth further study, but it’s not so promising that we should stop evaluating all those other hundreds of compounds and focus all our efforts on DCA. Not yet, anyway (though we can hope).

    B) DCA really is the miracle cure for cancer. Big pharma knows it, and they’ve instructed their lackeys at FDA to suppress it, thus protecting pharma’s profits.

    My money’s on A.

  19. #19 Coin
    July 23, 2007

    What if dichloroacetate is in fact really effective or what if apricot pits are in fact really effective.

    It’s been said in these threads before, but it’s worth saying again: if DCA is effective, it’s effective for some particular dosage, and dangerous for some particular dosage. Without knowing what those dosages are, DCA generally can’t be effective. Without performing studies, you can’t know what those dosages are.

    The FDA won’t let people take substances until these studies have been performed. That’s all.

  20. #20 Steven
    July 23, 2007

    Ok understood. I’m not pro-DCA myself. I have been following the forum at http://www.thedcasite.com for a while. It astounded me how people believe everything they read, including testimonials. Sometimes you see ‘hidden’ testimonials, such as: a person went to the medicor clinic and his tumor was totally gone in 24 days. People believe it because they want to believe it I think.

  21. #21 Steven
    July 24, 2007

    (frustrated)

    I don’t know what is wrong with the people at thedcasite.com (particularily the owners). May it be that dichloroacetate has altered their brain function??? After all, it is chemotherapy.

    They made clear 2 months ago that dichloroacetate is a “potentially dangerous”, “experimental” drug for “animals only”. Now they are implying that they have a wonderdrug.

  22. #22 bill
    August 9, 2007

    It makes me wonder if anyone who has posted here has actually had any experience with someone who has/is having chemotherapy for cancer.

    Traditional chemotherapy is very, very unpleasant, extremely toxic, can damage innocent tissue and organs and lead to the evolving of other cancers later in life – IF the patient survives. It destroys the immune system and leaves the patient open to a range of infections that can be themselves life threatening.

    Cheerfully prescribed by Doctors and Consultants.

    Sometimes chemotherapy can be taken in tablet form, but mostly intraveniously, which is very painful. Patients usually have to resort to a Hickman line as veins are destroyed.

    Often chemotherapy fails to work and the patient is left in a terminal situation where the medical fraternity admits there is no more that can be done.

    DCA is a chemical/drug that has been approved and in use for many years, albeit not for cancer treatment. The side effects are zero or minimal when used at low dosages.

    Generally, the testaments that are listed on the DCA website are from those people who are at the end and have nothing to lose as traditionalknown treatments have not worked.

    They are open and realistic about the beneficial effects (or otherwise) of using DCA both in isolation and combination with traditional chemotherapy and obviously, they are keen to share their experiences with fellow sufferers.

    How sad that some posts here have ‘nit-picked’ certain paragraphs from the DCA site to deride it instead of being more open about the contents.

    Much is said here about ‘process’, ‘authority’, ‘approval and ‘law’.

    My advice – go and spend two weeks on a cancer ward. When you are dying ‘process’, ‘authority’, ‘approval’ and ‘law’ have very little importance or meaning to the patient and family.

    I gave DCA to my son after repeated chemotherapy failed.

    No side effects, sickness, loss of hair or depleted immune system.

    Improved energy and (it was taken in combination with a repeated chemotherapy) it was the only time in 18 months that there was a regression of the cancer.

    Like many people who have posted on the DCA site, I am reasonably well educated (an Engineer with an Honours Degree) and analytical in my approach.

    The scientific establishment is often quick on criticism, but slow on support and often reluctant to step outside of established and protected regimes.

    Most of the world does not work that way.

  23. #23 bill
    August 9, 2007

    One more thing – does DCA work?

    Supposedly it works by interacting with Pyruvate Kinase.

    So,

    1. Look up in detail the DCA mechanism on the DCA site.

    2. Punch ‘Petty Spurge’ into Google. Apparently scientists have recently found that an extract from this common weed has cancer curing properties.

    3. Read up on the mechanism of what the extract does.

    4. “Say no more” – Monty Python

  24. #24 Oliver
    August 9, 2007

    “The scientific establishment is often quick on criticism, but slow on support and often reluctant to step outside of established and protected regimes.”

    The scientific establishment works through agreed-on methodology, because that’s what distinguishes science both from dilletant dabbling and from quackery. Criticising science for being science is only one thing: Plain out silly.

  25. #25 greg
    October 13, 2007

    your comments on Dcu.com

    BULL……………

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